THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA


INA-OOR8AXF
03-01-2024
27-12-2023
No
THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA
THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA
 
Faculty of Nursing, Chulalongkorn University of Thailand
The Indonesian Endowment Fund for Education-Ministry of Finance, The Republic of Indonesia (Grant Number: S-169/LPDP.4/2021).
No
 
Margareta Teli, SKep,Ns, MSc-PH, PhD (c)
Kota Kupang
Indonesia
1. Faculty of Nursing, Chulalongkorn University Bangkok, Bangkok, Thailand. 2. Nursing School, Polytechnic of Ministry of Health-Kupang, East Nusa Tenggara, Indonesia.
margarethateli@gmail.com
Margareta Teli, SKep,Ns, MSc-PH, PhD (c)
Jurusan Keperawatan, Poltekkes Kemenkes Kupang Jalan Piet A.Tallo, Liliba, Kupang, NTT RT/RW: 015/015, Kelurahan Liliba, Kecamatan Oebobo, Kota Kupang
Kota Kupang
Indonesia
85111
1. Faculty of Nursing, Chulalongkorn University Bangkok, Bangkok, Thailand. 2. Nursing School, Polytechnic of Ministry of Health-Kupang, East Nusa Tenggara, Indonesia.
margarethateli@gmail.com
+6281211975058
Professor Ratsiri Thato, PhD
Research Unit for Enhancing Well-being in Vulnerable and Chronic Illness Populations, Faculty of Nursing, Chulalongkorn University Borommaratchachonnani Srisataphat Building, Rama1 Road, Pathumwan, Bangkok 10330, Thailand
Bangkok
Thailand
10330
Faculty of Nursing, Chulalongkorn University Bangkok, Bangkok, Thailand
ratsiri.T@chula.ac.th; ratsiri99@gmail.com
 
LB.02.03/1/0202/2023
Komite Etik Penelitian dan Pengembangan Kesehatan Nasional-Politeknik Kesehatan Kemenkes Kupang, NUsa Tenggara Timur
22-11-2023
Komite Etik Penelitian dan Pengembangan Kesehatan Nasional (KEPK)-Politeknik Kesehatan Kemenkes Kupang, Nusa Tenggara Timur. Jalan Piet A. Tallo, Liliba Kupang, email : kepk@poltekkeskupang.ac.id, Telephone: (+62380)-8800256
Not applicable
 
Indonesia
12 Public Health Centres in Kupang City, East Nusa Tenggara, Indonesia
Recruit
03-12-2023
00068 -
120
23-12-2023
 
The study aims to compare HbA1c levels and HRQoL between adults with uncontrolled T2DM who receive the IFSM program and those who receive usual care.
Treatment
Interventional
Interventional, other than clinical trial
Randomized allocation
Multi-stage random sampling will be used to determine the adults with uncontrolled T2DM and their families who are registered in PHCs. Stage 01: Stratified random sampling will be used to select the study setting. Kupang City consists of 12 PHCs; which are located in the east, middle, and west; 4, 4, and 4 consecutively. Simple random sampling will be utilized to determine 3 PHCs from three geographic areas; one PHC in each area. Stage 02: When the three PHCs have been determined, the nurses at the public health centers will identify cases that meet the inclusion criteria. Furthermore, simple random sampling will be used to assign the subjects into intervention and control groups. Pair-matching will be performed to reduce bias by creating two comparable groups with similar baseline factors. Demographic factors that can cause variations in HRQoL and HbA1c include age, gender, and complications or comorbidities (Chantzaras & Yfantopoulos, 2022; Hamady et al., 2022; Kalayou Haftu et al., 2022; Liu et al., 2022; Wonde et al., 2022). Therefore, these factors will be used to form matched subject pairs. According to the inclusion criteria, patients who meet the eligible requirements will be matched 1: 1 based on the following factors; age (age ranged from 40-60, will be matched within 5 years), same gender, and similar comorbidities/complications; retinopathy, neuropathy, and hypertension). With these three conditions, the researchers randomly picked from the allocation concealment opaque envelope to assign the first subject to the assigned condition (experiment) and then the following subjects with similar matched pairs were placed in the second condition (control). The researcher will take into account if the following subject lives near the subject and has close family relationships with another condition to reduce the treatment diffusion.
The participants and the research assistants will be blind to the process. However, after the randomization and allocation, the blinding of the treatment allocation of participants is no longer possible.
The IFSM program will be administered to a cohort consisting of around 15-17 dyads, comprised of persons with suboptimal glycemic control and their respective family members. Consequently, the intervention group will be partitioned into two smaller subgroups. The researchers will invite the experimental participants to join the activities which consist of several activities, as follows:. 1. First (1st) Week: Face-to-Face Program (Friday and Saturday). Activities 1: Diabetes knowledge training. A 90-minute structured group education training that aims to improve the understanding of factual information about T2DM and self-management behaviors and their rationales will be conducted in the first week. The primary Investigator (PI) and co-investigators (Co-PI) will provide the education session, and module 01 will be given to the participants. The series of activities are, as follows; 1) The researchers build trusted relationships by implementing building learning commitment (BLC) through an introduction, ice-breaking, creating daily session objectives and expectations, and then posting on the blackboard in the class (5 minutes); 2) Providing short quizzes to determine their basic knowledge; (5 minutes); 3) Providing diabetes information: definition, diagnosis, signs and symptoms, complications with interesting images and a diabetes video presentation; (35 minutes); 4) The PI provides information about self-management behaviors and their rationale b: physical exercises, Diabetes Diet, Diabetes medication, and blood glucose monitoring by using Canva presentation design and infographics; (40 minutes); 5) The participants will be helped to evaluate their daily objectives by playing diabetes word games with answers (5 minutes). Activities 2: Self-Efficacy training. This session aims to enhance people with uncontrolled T2DM and their family’s belief or confidence to engage and maintain self-management behaviours to achieve glycemic control and improve the HRQoL. It will last 30 minutes and include the following activities; 1) Sharing and reflecting on the uncontrolled T2DM and their families’ beliefs about diabetes and DSM practices; 2) The researchers guide the discussion to change negative perceptions of diabetes and reinforce positive comments; 3) Sharing successful experiences from diabetic patients who experience the benefits of self-management behaviors and maintain their glycemic control. 2. Second (2nd) week: Self-regulation Training (Saturday) This third session will be carried out in 120-minute meetings in the second week (Friday). This session is designed to achieve change in diabetes self-management behaviours of people with uncontrolled T2DM and their families by practicing self-regulation skills and abilities. Therefore, to achieve these goals, the activities will be; 1) The researchers assist those with uncontrolled T2DM and their families in developing personal and family goals for self-management of diabetes (10 minutes); 2) The PI guide for reflective thinking to identify the possible barriers and challenges of DSM (5 minutes); 3) The researchers present a weekly meal planning form and direct individuals with uncontrolled T2DM and their families to create calorie-based meal plans for their diabetes (25 minutes); 4) The researchers present the weekly exercise planning form and instruct individuals with uncontrolled type 2 diabetes (T2DM) and their families on how to create their weekly activity planners (150 minutes of walking per week or 30 minutes per day). (15 minutes); 5) The researchers explain the planning form for self-monitoring blood sugar levels and assist persons with uncontrolled T2DM and their families in creating their planner (5 minutes); 6) The researchers explain the diabetes medication diary and assist persons with uncontrolled T2DM and their families in creating planners (5 Minutes); 7) The researchers give the families instructions on how to use and fill out the Diabetes Self-Management Monitoring Checklist (5 minutes); and 8) Talk about the family's responsibilities in SMB, such as taking patients to appointments, preparing food, rescheduling time for meals, complying with many kinds of medicine, and emotional support to cope with the long-term follow-up care of diabetes helping patients, and initiating change in exercise (10 minutes) 3. Week 3, 5, 7, and 9: Family phone calls (every Tuesday) This program aims to promote family discussion and provide ongoing encouragement for SMB performance. The PI and co-PI will make 15-20-minute phone calls to the families in weeks 3, 5, 7, 9, and 11. Week 3: Set up a situation that is convenient for phone calls, listen attentively, and carefully assess each person's weekly meal plan, weekly exercise schedule, diabetes medications, and blood sugar monitoring on week 3. Do they adhere to the strategy? amplify any form of accomplishment. Additionally, the phone conversations highlight any obstacles or hurdles to implementing the DSM weekly plan and serve as a motivator and reminder of the diabetes SMB's key message (table 01). Week 5: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 03 and 04. Discuss the challenges or progress, provide motivation, and remind the key message of diabetes SMB (diet, Physical exercise, Medication adherence, Blood glucose monitoring) (table 01). Week 7: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 05 and 06. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, Medication adherence, Blood glucose monitoring) (table 01). Week 9: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 07 and 08. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, medication adherence, blood glucose monitoring) (table 01). Week 11: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 07 and 08. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, medication adherence, blood glucose monitoring) (table 01). Moreover, the assessment of diabetes self-management behaviors acquired by the participant from all these weeks by checking their weekly or monthly plan of DSM. 4. Week 4, 6, 8, 10, and 12; Delivering the SMB infographics (Monday, Wednesday, and Friday) Several SMB infographics and motivational messages will be delivered every Monday, Wednesday, and Friday which aim to motivate and remind them to keep performing the SMB (Appendix B). The SMB infographic will be sent at around 12-1 PM and will be checked at around 6 PM. Reminder messages to read the cards will be sent at around 6.30 PM. The diabetes infographics that will be delivered to WA groups involve diabetes medication, physical exercise: healthy eating, blood sugar monitoring, and family roles.
The control group will receive the usual care provided by nurses during the Chronic Disease Management Program (PROLANIS) activities. They will receive main activities consisting of measuring blood pressure, checking blood glucose levels, and diabetes education. Furthermore, regarding the issue of equity and providing equivalent benefits to the control group, the modules, and infographics will be provided for the control group after the study is finished. Additionally, the program will be made available to the control group once the study is completed, which address the issue of equity and provide the control group with advantages that are equivalent to those received by the study participants.
Parallel
 
Male, Female
40
65
Sample selection will be based on the sample size frame. Eligible participants will be recruited by the following inclusion criteria:
1.adults with uncontrolled T2DM (HbA1c ≥7 %),
2.age 40-65 years (highest prevalence of T2DM),
3.have already living with diabetes for less than 10 years
4.use oral antidiabetics (OAD),
5.be able to communicate (both verbal and written);
6.agree to undergo the whole process of the IFSM program;
7.have a smartphone with internet access,
8.not enroll in another research program and have family members living with them.
The discontinuation criteria include hospital admissions due to acute complications or surgery.

Meanwhile, the inclusion criteria for the family members include;
1.living in the same residence and having contact with the patient regularly,
2.Being a spouse or child who actively participates in the IFSM program and plays a crucial role in assisting its implementation within the home setting (the family members will be nominated by patients);
3.being willing to provide informed consent.
4.aged 18 years or older
The exclusion criteria consist of the following criteria:
1. those who previously participated in diabetes intervention, and
2. patients with diabetes-related severe complications.
 
The main outcomes of this study consist of: 1. Glycated Hemoglobin (HbA1c) 2. Health related quality of Life (HRQoL)
1. Glycated Hemoglobin (HbA1c) Glycated Hemoglobin (HbA1c) will be measured by using a Biohermes A1C EZ HbA1c analyzer. The A1C EZ 2.0 analyzer can precisely measure a patient’s HbA1c level which completes the test within 5 min, requires only about 3 microliters of capillary blood sample, and has been certified by The International Federation of Clinical Chemistry (Zhou et al., 2018). The A1C EZ 2.0 has high accuracy and precision compared to a comparative laboratory instrument (Kwon & Kim, 2022; Wang et al., 2018; Zhou et al., 2018). Moreover, it met analytical quality specifications and could be suitable for the clinical management of DM, the sensitivity and specificity were 76.1% and 86.6% (Wang et al., 2018). 2. The Quality of Life Instrument for Diabetes Patients (QOLID) The QOLID developed by Nagpal et al., (2010) will be used in this study. The QOLID has been translated into Indonesia. The QOLID is a reliable, valid, and comprehensive instrument that is suitable for measuring the QoL specific to diabetes (Langendoen-Gort et al., 2022; Nagpal et al., 2010). Moreover, four domains were responsive to clinical change in metabolic control (Oluchi et al., 2021). The QOLID questionnaire offers a holistic insight into patients’ needs and expectations from disease management in terms of 8 domains comprised of role limitation due to physical health, physical endurance, general health, treatment satisfaction, symptom botherness, financial worries, emotional/mental health, and diet advice tolerance. The validated tool had 34 items (questions). The final questionnaire had an overall Cronbach’s alpha value of 0.894 (subscale: 0.55 to 0.85), showing high internal consistency in the current study population (Nagpal et al., 2010)
The baseline measurement of HbA1c value and HRQoL will be conducted during week 0, while the post-test measurement will be carried out at week 12, subsequent to the delivery of the IFSM Program to the intervention group
 
Currently, a total number of 52 dyads (uncontrolled T2DM patients and 1 family member) from 2 public health centers indicated they were willing to participate in part in this research and were examined for eligibility. The mean age of recruited individuals was 58 years old, and the mean HbA1c level was about 8,84%. While the mean of HRQoL was 82.35. The participants at one Public health centre are still in the process of recruitment.
 
No
Currently, this research is in the recruiting phase, the intervention will be begun in January-March 2023.